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Related Concept Videos

Bioequivalence: Overview01:16

Bioequivalence: Overview

Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
Drug Biotransformation: Overview01:16

Drug Biotransformation: Overview

Pharmaceutical substances known as xenobiotics are predominantly lipophilic and nonionized. This enables them to permeate lipid bilayers, such as cell membranes, and interact with intracellular target receptors. Lipophilic drugs have an advantage in crossing biological barriers and reaching their intended sites of action. However, lipophilic drugs often have a restricted capacity for renal expulsion or elimination from the body. When these drugs enter the kidneys and undergo glomerular...
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
Bioavailability: Overview01:13

Bioavailability: Overview

Bioavailability refers to the proportion of an unaltered drug that, after administration, enters the systemic circulation and can be distributed to the desired action site. Factors such as gastrointestinal (GI) absorption and liver biotransformation influence the bioavailability of a drug when it is administered orally. When a drug is administered intravenously, it enters the systemic circulation directly; by definition, its bioavailability is assumed to be 100%. The bioavailability of an...
Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...

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Related Experiment Video

Updated: May 30, 2026

Updated Protocol for the Assembly and Use of the Minibioreactor Array (MBRA)
09:38

Updated Protocol for the Assembly and Use of the Minibioreactor Array (MBRA)

Published on: September 5, 2025

[Update of BIOBADASER].

Loreto Carmona1,

  • 1Unidad de Investigación, Fundación Española de Reumatología, Madrid, España.

Reumatologia Clinica
|July 29, 2011
PubMed
Summary

Biological therapies are frequently discontinued due to adverse events or lack of effectiveness. Infections are the most common adverse events reported in patients undergoing biological therapies.

Area of Science:

  • Pharmacovigilance
  • Immunology
  • Drug safety

Context:

  • BIOBADASER database analysis as of September 1st, 2008.
  • Includes data from 100 centers and 9,352 patients.
  • Covers 12,136 treatments with biological therapies.

Purpose:

  • To analyze the reasons for discontinuation of biological therapies.
  • To identify the most frequent adverse events associated with biological therapies.

Summary:

  • Treatment discontinuation occurred in 35% of cases (4,281 patients).
  • Reasons for discontinuation were equally split between adverse events (42%) and inefficiency/loss of effectiveness (42%).
  • 6,814 adverse events were reported, with infections being the most common (39%), followed by administration-related disorders (15%) and skin/subcutaneous tissue disorders (8%).

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Published on: May 15, 2019

Online Size-exclusion and Ion-exchange Chromatography on a SAXS Beamline
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Online Size-exclusion and Ion-exchange Chromatography on a SAXS Beamline

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Related Experiment Videos

Last Updated: May 30, 2026

Updated Protocol for the Assembly and Use of the Minibioreactor Array (MBRA)
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Updated Protocol for the Assembly and Use of the Minibioreactor Array (MBRA)

Published on: September 5, 2025

Using the Open-Source MALDI TOF-MS IDBac Pipeline for Analysis of Microbial Protein and Specialized Metabolite Data
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Using the Open-Source MALDI TOF-MS IDBac Pipeline for Analysis of Microbial Protein and Specialized Metabolite Data

Published on: May 15, 2019

Online Size-exclusion and Ion-exchange Chromatography on a SAXS Beamline
11:09

Online Size-exclusion and Ion-exchange Chromatography on a SAXS Beamline

Published on: January 5, 2017

Impact:

  • Highlights the significant rates of discontinuation for biological therapies.
  • Identifies key safety concerns, particularly infections, associated with biological treatments.
  • Provides crucial data for improving patient management and therapeutic strategies in biological therapy use.